510(k) · Cleared
ClearedArthrex Tibial Graftbolt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Mar 18, 2010 as substantially equivalent to K032167 (Mitek Worldwide, 2003) and 1 other predicate after an 86-day review. Its family tree reaches back 5 generations to 1997. 3 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 86 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971358 (1997). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 4 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 3 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 2 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 1 generation backK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
- This deviceK093912 Arthrex Tibial GraftboltArthrex, Inc. · 2010
- Descendant · cites it directly · 2 of its ownK103060 Arthrex Tibial GraftboltArthrex, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK253130 Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK120540 BioboltArthrex, Inc. · 2012
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −4 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −3 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −2 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −1 | K032167 | Bio-Intrafix Tibial Screw and Sheath | Mitek Worldwide | 2003 | — |
| 0 (this device) | K093912 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2010 | — |
| +1 | K103060 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2011 | — |
| +2 | K253130 | Dione PEEK Screw System | ZheJiang Decans Medical Devices Co., Ltd. | 2026 | — |
| +1 | K120540 | Biobolt | Arthrex, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBI device
- #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032167 | Bio-Intrafix Tibial Screw and SheathSummary page 1…Common Name Screw, Fixation, Bone ClassfilcatIon Name Smooth or threaded metallic bone fixation fastener Regulation No. 888.3040 Th-edicage Devices K032167: Bio-1ntrafixThm Tibial Screw and Sheath - Mitek Worldwide K083607: AperFixg Tibial Implant with Inserte… | 2003 |
| * | K083607 | Aperfix Implant with Inserter, 8, 9, 10, 11, MM X30 MMSummary page 1…e fixation fastener Regulation No. 888.3040 Th-edicage Devices K032167: Bio-1ntrafixThm Tibial Screw and Sheath - Mitek Worldwide K083607: AperFixg Tibial Implant with Inserter - Cayenne Medical Device Desefipton The Anthrex Tibial GrafiBoft consists of a pre-pa… | 2009 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K103060 (Arthrex, Inc., 2011) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K032167.
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 2025
MAUDE reports naming product code MBI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 80 | 24 | 240 |
| 2008 | 10 | 69 | 6 | 338 |
| 2009 | 19 | 82 | 2 | 355 |
| 2010 | 17 | 76 | 3 | 291 |
| 2011 | 30 | 75 | 23 | 328 |
| 2012 | 24 | 94 | 6 | 371 |
| 2013 | 31 | 100 | 2 | 442 |
| 2014 | 23 | 101 | 0 | 504 |
| 2015 | 23 | 85 | 0 | 507 |
| 2016 | 17 | 94 | 0 | 795 |
| 2017 | 17 | 70 | 4 | 675 |
| 2018 | 16 | 91 | 2 | 1,072 |
| 2019 | 31 | 90 | 0 | 1,303 |
| 2020 | 35 | 83 | 1 | 1,454 |
| 2021 | 18 | 107 | 0 | 1,890 |
| 2022 | 19 | 64 | 0 | 1,591 |
| 2023 | 52 | 57 | 1 | 2,503 |
| 2024 | 22 | 30 | 1 | 3,779 |
| 2025 | 27 | 58 | 1 | 3,826 |
| 2026 | 30 | 63 | 0 | — |
What is it indicated for?
The Arthrex Tibial GraftBolt is intended to be used for fixation of tissue including ligament or tendon to bone and bone tendon during cruciate ligament reconstruction procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093912 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093912: Arthrex Tibial Graftbolt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093912
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026